# DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

- Device class: 2; regulation: 21 CFR 870.4210; FDA's rule: 510(k) required
- FDA decisions: 403
- 510(k) review time 2021–2025: median 110 days (middle half 50–234)
- Recalls: 250 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 5
- 2018: 5
- 2019: 3
- 2020: 3
- 2021: 5
- 2022: 2
- 2023: 2
- 2024: 3
- 2025: 4
- 2026: 8

## Most-cited predicates
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer (1993), cited by 10
- K790565: Aortic Root Cannula (1979), cited by 8
- K880103: Catheter, Cannula and Tubing, Vascular, Cardiopul. (1988), cited by 7
- K891576: Fem-Flex Femoral Access Cannulation Set (1989), cited by 6
- K081820: Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR (2008), cited by 5
- K934127: Sarns Low Jetting Aortic Arch Cannula (1994), cited by 5
- K770429: Cannulae, Aortic, Arch, High Flow (1977), cited by 5
- K033416: Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface (2003), cited by 4
- K831769: Various Cardiovascular Surgical Device (1983), cited by 4
- K943934: Aortic Arch Cannulas (1995), cited by 4

Source page: https://510kreport.com/product-code/DWF
Data by year (CSV): https://510kreport.com/product-code/DWF.csv